Health Mart Extra Strength Pain Relief
FDA Label NDC 62011-0329

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Health Mart Extra Strength Pain Relief (NDC 62011-0329). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                            Purpose

Menthol 5%...................................................Topical analgesic

Otc - Purpose

Uses temporarily relieves pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away.

Indications & Usage

Directions

adults and children over 12 years:

  • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • carefully remove backing from patch
  • apply one patch to affected area
  • wear one patch up to 8 hours
  • repeat as necassary, but no more than 4 times daily

    • children 12 years or younger:

    • consult a doctor

Storage And Handling

Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient

Inactive ingredients

1,3 butylene glcol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Dosage & Administration

Distributed by:

McKesson

One Post Street

San Franciso, CA 94104

Made in Korea

Package Label.Principal Display Panel

Image Description (14077.2)

Image Description (14077.2)

* Please review the disclaimer below.